Healthy VolunteersPhase 1NCT05845996
Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects
A Phase 1 study testing SAR441344 and Keyhole limpet hemocyanin in people with Healthy Volunteers, run by Sanofi at 1 site in United States.
Trial summary
Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SAR441344 and Keyhole limpet hemocyanin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2018to 10 Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having given written informed consent prior to undertaking any study-related procedure.
Who cannot join
- Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Parallel Design, Placebo-controlled Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Doses of SAR441344 in Healthy Adult Subjects
Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344
Read the detailed description
The study duration of Part 1 is approximately 22 weeks, including a treatment period of 1 day; The study duration of Part 2 is approximately 26 weeks for each subject, including a treatment period of 29 days.
- Conditions
- Healthy Volunteers
- Being tested
- SAR441344, placebo, Keyhole limpet hemocyanin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR441344Drug
Solution for intravenous/subcutaneous injection
placeboDrug
Solution for intravenous/subcutaneous injection
Keyhole limpet hemocyaninBiological
Subcutaneous Lyophilized powder for reconstitution
| Study group | Role | What they receive |
|---|---|---|
| SAR441344 | Experimental | Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously Receives: Drug: SAR441344; Biological: Keyhole limpet hemocyanin |
| placebo | Placebo comparator | matching placebo Receives: Drug: placebo; Biological: Keyhole limpet hemocyanin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of participants with adverse event(AE)
Number of participants with AE from baseline to day 127
Measured: From baseline to day 127
Part 2: Number of participants with adverse event (AE)
Number of participants with AE from baseline to day 155
Measured: From baseline to day 155
Secondary outcomes (12)
Assessment of PK parameter: Cmax
Maximum plasma concentration (Cmax) observed
Measured: From Day 1 to Day 127 and to Day 155
Assessment of PK parameter: tmax
First time to reach Cmax (tmax)
Measured: From Day 1 to Day 127 and Day 155
Assessment of PK parameter: AUClast
Area under the plasma concentration versus time curve from time zero to the real time
Measured: From Day 1 to Day 127
Assessment of PK parameter: AUC
From Day 1 to Day 127
Measured: Area under the plasma concentration versus time curve extrapolated to infinity
Assessment of PK parameter: AUC0-tau
Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (336 hours)
Measured: From day 1 to Day 155
Assessment of PK parameter: Ctrough
Plasma concentration observed just before treatment administration during repeated dosing
Measured: From Day 1 to Day 155
Assessment of PK parameter: t1/2z
Terminal half-life associated with the terminal slope (λz)
Measured: From Day 1 to Day 127 and Day 155
Assessment of PK parameter: CL(/F)
From Day 1 to Day 127
Measured: Apparent total body clearance of a drug from the plasma
Assessment of PK parameter: CLss(/F)
From day 1 to Day 155
Measured: Apparent total body clearance of a drug from the plasma
Anti-SAR441344 antibodies
Number of subjects with treatment emergent anti-drug antibody formation
Measured: From Day 1 to Day 127 and Day 155
Assessment of anti-KLH IgG and IgM
Measurement of anti-KLH IgG and IgM levels in response to KLH immunization
Measured: From Day 1 to Day 127 and Day 155
AE attributed to KLH immunization
Number of participants with AE attributed to KLH immunization
Measured: From Day 1 to Day 127 and Day 155
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start8 Nov 2018
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845996
- Sponsor's protocol ID
- TDU15525-TDR15526
- Other IDs
- U1111-1217-2909
- Status last verified
- Sep 2025
- First submitted
- 26 Apr 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Design, Placebo-controlled Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Doses of SAR441344 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05845996
- Acronym / sponsor ID
- TDU15525-TDR15526
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344
Detailed description
The study duration of Part 1 is approximately 22 weeks, including a treatment period of 1 day; The study duration of Part 2 is approximately 26 weeks for each subject, including a treatment period of 29 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR441344 | Experimental | Drug: SAR441344, Biological: Keyhole limpet hemocyaninSingle or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously |
| placebo | Placebo comparator | Drug: placebo, Biological: Keyhole limpet hemocyaninmatching placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Having given written informed consent prior to undertaking any study-related procedure.
Key exclusion criteria (2 listed)
- Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR441344Solution for intravenous/subcutaneous injection | Drug | SAR441344 |
| placeboSolution for intravenous/subcutaneous injection | Drug | placebo |
| Keyhole limpet hemocyaninSubcutaneous Lyophilized powder for reconstitution | Biological | SAR441344, placebo |
Primary outcome
Part 1: Number of participants with adverse event(AE)
Time frame: From baseline to day 127
Number of participants with AE from baseline to day 127
Part 2: Number of participants with adverse event (AE)
Time frame: From baseline to day 155
Number of participants with AE from baseline to day 155
12 secondary outcomes
Assessment of PK parameter: Cmax
Time frame: From Day 1 to Day 127 and to Day 155
Assessment of PK parameter: tmax
Time frame: From Day 1 to Day 127 and Day 155
Assessment of PK parameter: AUClast
Time frame: From Day 1 to Day 127
Assessment of PK parameter: AUC
Time frame: Area under the plasma concentration versus time curve extrapolated to infinity
Assessment of PK parameter: AUC0-tau
Time frame: From day 1 to Day 155
Assessment of PK parameter: Ctrough
Time frame: From Day 1 to Day 155
Assessment of PK parameter: t1/2z
Time frame: From Day 1 to Day 127 and Day 155
Assessment of PK parameter: CL(/F)
Time frame: Apparent total body clearance of a drug from the plasma
Assessment of PK parameter: CLss(/F)
Time frame: Apparent total body clearance of a drug from the plasma
Anti-SAR441344 antibodies
Time frame: From Day 1 to Day 127 and Day 155
Assessment of anti-KLH IgG and IgM
Time frame: From Day 1 to Day 127 and Day 155
AE attributed to KLH immunization
Time frame: From Day 1 to Day 127 and Day 155
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- TDU15525 Plain Language Results SummaryLink provided by the sponsor.
- TDR15526 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR441344 and Keyhole limpet hemocyanin in people with Healthy Volunteers, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of participants with adverse event(AE) (time frame: From baseline to day 127). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.